C - Chemistry – Metallurgy – 07 – K
Patent
C - Chemistry, Metallurgy
07
K
C07K 1/04 (2006.01) C07K 14/815 (2006.01)
Patent
CA 2618494
The invention relates to methods for the preparation of high purity Bivalirudin on a hyper acid-labile resin. The polypeptide is prepared in a high purity of at least 98.5% (by HPLC) , wherein the total impurities amount to less than 1.5%, comprising not more than 0.5% [Asp9- Bivalirudin] and each is impurity less than 1.0%, and preferably having a purity of at least about 99.0% by HPLC, wherein the total impurities amount to less than 1.0%, comprising not more than 0.5% [Asp9-Bivalirudin] and each impurity is less than 0.5%.
L~invention concerne des procédés destinés à la préparation de Bivalirudine de pureté élevée. Le polypeptide est préparé à une pureté élevée d~au moins 98,5 % (par HLPC), la quantité totale d~impuretés étant inférieure à 1,5 %, ne comprenant pas plus de 0,5 % de [Asp9- Bivalirudine] et chaque impureté étant inférieure à 1,0 %, et de préférence présentant une pureté d~au moins environ 99,0 % par HLPC, la quantité totale d~impuretés étant inférieure à 1,0 %, ne comprenant pas plus de 0,5 % de [Asp9-Bivalirudine] et chaque impureté étant inférieure à 0,5 %.
Bar-Oz Leah
Butilca Gabriel-Marcus
Eidelman Chaim
Gadi Tehila
Hagi Alon
Heenan Blaikie Llp
Novetide Ltd.
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